Company
United StatesOrtho-Clinical Diagnostics, INc., Rochester, NY – FDA Inspections
Inspection records and compliance data for Ortho-Clinical Diagnostics, INc. in Rochester, New York. 1 FDA inspection on record, 1 Form 483, last inspected March 27, 2017.
Company Profile
This profile covers Ortho-Clinical Diagnostics, INc. based in Rochester, New York, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected March 27, 2017.
Most cited issue areas
- Complaints1 inspection
- Design validation - Risk analysis1 inspection
- Lack of or inadequate procedures for handling1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 27, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1012400 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ortho-Clinical Diagnostics, INc.
FEI Number
1000305840
Address
513 Technology Blvd, Rochester, New York 14626, United States
Country
United States
ID: 664f1141-6bf0-4656-a1d5-d26683979460